NDC 64764-510

Actoplus Met XR

Pioglitazone And Metformin Hydrochloride

Actoplus Met XR is a Oral Tablet, Film Coated, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Pioglitazone Hydrochloride; Metformin Hydrochloride.

Product ID64764-510_12f6dfdd-309c-44a9-86bf-664c449f5ddb
NDC64764-510
Product TypeHuman Prescription Drug
Proprietary NameActoplus Met XR
Generic NamePioglitazone And Metformin Hydrochloride
Dosage FormTablet, Film Coated, Extended Release
Route of AdministrationORAL
Marketing Start Date2010-06-11
Marketing End Date2022-09-30
Marketing CategoryNDA / NDA
Application NumberNDA022024
Labeler NameTakeda Pharmaceuticals America, Inc.
Substance NamePIOGLITAZONE HYDROCHLORIDE; METFORMIN HYDROCHLORIDE
Active Ingredient Strength15 mg/1; mg/1
Pharm ClassesPeroxisome Proliferator-activated Receptor Activity [MoA],PPAR alpha [CS],PPAR gamma [CS],Thiazolidinedione [EPC],Thiazolidinediones [CS],Peroxisome Proliferator Receptor alpha Agonist [EPC],Peroxisome Proliferator Receptor gamma Agonist [EPC],Biguanide [EPC],Biguanides [CS]
NDC Exclude FlagN

Packaging

NDC 64764-510-07

1 BLISTER PACK in 1 CARTON (64764-510-07) > 7 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK
Marketing Start Date2010-06-11
Marketing End Date2022-09-30
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 64764-510-33 [64764051033]

Actoplus Met XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022024
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2022-09-30

NDC 64764-510-60 [64764051060]

Actoplus Met XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022024
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2022-09-30

NDC 64764-510-90 [64764051090]

Actoplus Met XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022024
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2022-09-30

NDC 64764-510-07 [64764051007]

Actoplus Met XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022024
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-06-11
Marketing End Date2022-09-30

NDC 64764-510-30 [64764051030]

Actoplus Met XR TABLET, FILM COATED, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA022024
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2010-06-11
Marketing End Date2022-09-30

Drug Details

Active Ingredients

IngredientStrength
PIOGLITAZONE HYDROCHLORIDE15 mg/1

OpenFDA Data

SPL SET ID:f986164c-51a7-41c2-8952-511b8f46d593
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 899989
  • 899993
  • 899996
  • 900000
    • UPC Code
  • 0364764310301
  • 0364764510305

    • Pharmacological Class

    • Biguanide [EPC]
    • Biguanides [CS]
    • Peroxisome Proliferator-activated Receptor Activity [MoA]
    • PPAR alpha [CS]
    • PPAR gamma [CS]
    • Thiazolidinedione [EPC]
    • Thiazolidinediones [CS]
    • Peroxisome Proliferator Receptor alpha Agonist [EPC]
    • Peroxisome Proliferator Receptor gamma Agonist [EPC]

    Medicade Reported Pricing

    64764051030 ACTOPLUS MET XR 15-1,000 MG TB

    Pricing Unit: EA | Drug Type:

    NDC Crossover Matching brand name "Actoplus Met XR" or generic name "Pioglitazone And Metformin Hydrochloride"

    NDCBrand NameGeneric Name
    64764-155Actoplus Metpioglitazone and metformin hydrochloride
    64764-158Actoplus Metpioglitazone and metformin hydrochloride
    64764-310Actoplus Metpioglitazone and metformin hydrochloride
    64764-510Actoplus Metpioglitazone and metformin hydrochloride
    0093-7677Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    0093-7678Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    42291-512Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride
    42291-513Pioglitazone and Metformin HydrochloridePioglitazone and Metformin Hydrochloride

    Trademark Results [Actoplus Met]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ACTOPLUS MET
    ACTOPLUS MET
    78218773 3149378 Live/Registered
    TAKEDA PHARMACEUTICAL COMPANY LIMITED
    2003-02-25
    ACTOPLUS MET
    ACTOPLUS MET
    78174989 not registered Dead/Abandoned
    Takeda Chemical Industries, Ltd.
    2002-10-16
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